The US FDA has simultaneously approved Thermo Fisher Scientific’s NGS CDx to identify NSCLC patients eligible for treatment using Exkivity
Takeda has obtained the US Food and Drug Administration (FDA) approval for Exkivity (mobocertinib) to treat a type of non-small cell lung cancer (NSCLC).
The drug was indicated for metastatic NSCLC in adults with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, following platinum-based chemotherapy.
Exkivity is an oral tyrosine kinase inhibitor (TKI), designed to selectively target epidermal growth factor receptor (EGFR) Exon20 insertion mutations.
Prior to the approval, the drug was granted priority review, received Breakthrough Therapy Designation, Fast Track Designation and Orphan Drug Designation from the FDA.
The Japanese drugmaker said that its Exkivity is the first and only approved oral therapy specifically designed to target EGFR Exon20 insertion mutations.
Takeda global oncology business unit president Teresa Bitetti said: “The approval of EXKIVITY introduces a new and effective treatment option for patients with EGFR Exon20 insertion+ NSCLC, fulfilling an urgent need for this difficult-to-treat cancer.
“EXKIVITY is the first and only oral therapy specifically designed to target EGFR Exon20 insertions, and we are particularly encouraged by the duration of the responses observed with a median of approximately 1.5 years.
“This approval milestone reinforces our commitment to meeting the needs of underserved patient populations within the oncology community.”
Results from the Phase 1/2 trial of Exkivity, in 114 patients with EGFR Exon20 insertion+ NSCLC who received prior platinum-based therapy, supported the FDA approval.
The study showed an overall response rate of ORR of 28%, median overall survival (OS) of 24 months and a median progression-free survival (PFS) of 7.3 months.
Most common adverse reactions include diarrhoea, rash, nausea, stomatitis, vomiting, decreased appetite, paronychia, fatigue, dry skin, and musculoskeletal pain.
The US regulator reviewed the drug under its Project Orbis initiative, and approved drug under the accelerated approval.
Furthermore, FDA has approved Thermo Fisher Scientific’s Oncomine Dx Target Test as an NGS companion diagnostic (CDx) for identify NSCLC patients eligible for Exkivity treatment.
NGS testing is said to enable more accurate diagnoses compared to polymerase chain reaction (PCR) testing, which detects less than 50% of EGFR Exon20 insertions.